Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 8:36 AM
Study NCT ID:
NCT01363635
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2011-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2011-05-28', 'studyFirstSubmitQcDate': '2011-05-28', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of severe sepsis/septic shock on admission to the general surgical ICU', 'timeFrame': '5 year', 'description': 'Incidence of severe sepsis and septic shock on admission to the general surgical ICU'}], 'secondaryOutcomes': [{'measure': 'risk factors associated with poor outcome (organ failure, prolonged ICU length of stay and ICU death)', 'timeFrame': '5 year', 'description': 'organ failure (Stroke, AKI, PMI,ARDS), Mortality (ICU, 28 and 90 days) mortality and cause of mortality'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe sepsis/septic shock', 'organ failure', 'AKI', 'PMI', 'ALI', 'Stroke', 'ICU death'], 'conditions': ['Septic Shock', 'Multiple Organ Failure', 'Fatal Outcome']}, 'referencesModule': {'references': [{'pmid': '21516036', 'type': 'RESULT', 'citation': 'Zahar JR, Timsit JF, Garrouste-Orgeas M, Francais A, Vesin A, Descorps-Declere A, Dubois Y, Souweine B, Haouache H, Goldgran-Toledano D, Allaouchiche B, Azoulay E, Adrie C. Outcomes in severe sepsis and patients with septic shock: pathogen species and infection sites are not associated with mortality. Crit Care Med. 2011 Aug;39(8):1886-95. doi: 10.1097/CCM.0b013e31821b827c.'}]}, 'descriptionModule': {'briefSummary': 'Severe sepsis/septic shock are serious complications of infection with high morbidity and mortality. Recent information showed that early and aggressive resuscitation may help improving survival and outcome especially the resuscitation within the first 3 hours. In surgical patients, either severe sepsis/septic shock bought them to the operating room or this sepsis might be found after surgery resulting in higher morbidity and mortality. Not only knowledge management, others possible risk factors should also be identified and corrected for outcome improving. This prospective observational study will be done in 800 adult surgical patients admitting to the general surgical intensive care unit. Incidence of severe sepsis/septic shock on admission along with risk factors associated with poor outcomes \\[organ failure (AKI, ALI, PMI, liver failure, stroke), prolonged ICU length of, stay, ICU death\\] will be recorded especially effect of amount and type of fluid replacement in the first 6 hours, 24, 48 and 72 hours after diagnosis. Outcome as major organ failure, ICU length of stay, ICU, 28 and 90 days mortality will also be study.', 'detailedDescription': 'Consecutive severe sepsis/ septic shock patients who will be admitted to the general surgical ICU of Siriraj Hospital, Mahidol University, Bangkok, Thailand will be recruited to this study. Apart from demographic data (age, sex, BMI, comorbidity), detail of septic shock and resuscitation (preoperative and intraoperative resuscitation), vasopressor and steroid used, type and amount of fluid, blood and blood component used and shock reversal time. Complication associated with surgery, anesthesia and in ICU will also recorded. Clinical outcome as organ failure (Stroke, PMI, aki, ARDS); ventilator day, ICU and hospital length of stay, mortality (in ICU, 28 and 90 days mortality) and cause of mortality will be carefully recorded'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult surgical patient admiitiing to the general surgical ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\> 18 years) surgical patient admitting to the general surgical ICU\n* Consent to this study\n\nExclusion Criteria:\n\n* Patient undergoing cardiothoracic surgery, neurosurgery and traumatic surgery\n* Not consent to this study'}, 'identificationModule': {'nctId': 'NCT01363635', 'briefTitle': 'Severe Sepsis/Septic Shock on Admission to the General Surgical ICU', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Severe Sepsis/Septic Shock on Admission to the General Surgical ICU', 'orgStudyIdInfo': {'id': 'Si199/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'severe sepsis', 'description': 'severe sepsis/septic shock, organ failure, ICU death'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suneerat Kongsayreepong, MD', 'role': 'CONTACT', 'email': 'suneerat.kon@mahidol.ac.th', 'phone': '(661) 8427419'}, {'name': 'Onuma Chailwat, MD', 'role': 'CONTACT', 'email': 'onuma27@hotmail.com', 'phone': '(664)-3882104'}, {'name': 'Suneerat Kongsayreepong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICU Siamitra and ICU salad-Sumang, Deaprtment of Anesthesiology, Siriraj Hospital, Faculty of Medicine, Mahidol UNiversity, Bangkok, Thailand'}], 'centralContacts': [{'name': 'Suneerat Kongsayreepong, MD', 'role': 'CONTACT', 'email': 'suneerat.kon@mahidol.ac.th', 'phone': '(661) 8427419'}, {'name': 'Onuma Chaiwat, MD', 'role': 'CONTACT', 'email': 'onuma27@hotmail.com', 'phone': '(664)-3882104'}], 'overallOfficials': [{'name': 'Suneerat Kongsayreepong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital, Mahidol University, Bnagkok, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Suneerat Kongsayreepong, MD', 'investigatorAffiliation': 'Mahidol University'}}}}